BIOTECH BUZZ, April, 2013

Join the Committee on LinkedIn!

The Biotech committee is now a sub-group on Linked-In.  We can use this social networking group to better keep in touch with each other.  For example, the linked in page will allow you to send messages to each other or engage in group discussions and informal polls without clogging the inboxes of people who do not wish to participate. 

Also, for those of you who are interested in getting more involved, the Linked-In group will be used by subcommittee chairs to call for volunteers on projects and to announce events, such as CLE webinars or interesting news items.

Of course, participation is voluntary.  If interested in joining, please follow the directions below.

Step 1.  If you are not a member of Linked-In, please join.  It’s free.  Just click on the following link and follow the directions: https://www.linkedin.com/reg/join.

Step 2. Once you have joined, go to the search spot at top (look for the magnifying glass).

Step 3.  Search “American Intellectual Property Law Association” and request to join.

Step 4.  Go back to the Search bar, search for “AIPLA FDA Committee”, and request to join.  You can restrict by “group” using the drop down menu just to the left of the search bar.  Also, joining the main AIPLA group is required because you have to join the main group to join any subgroup, such as the Biotech committee.  For each request to join, it should say that your approval is pending.  The AIPLA IT staff will check that you are actually a member, and if so, approve you.

Step 5.  Start posting.

If you have any questions, please contact William Childs at William.Childs@dbr.com.

Programs

AIPLA Spring Meeting, Seattle Westin Hotel, May 1-3, 2013

May 2, 3:30 – 5:30, Biotechnology IP Practice in Latin America (120 Minutes of CLE)

The Biotechnology Committee and the IP Practice in Latin America Committee are collaborating to present 2 hours of CLE on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. The topics to be addressed will cover (1) status of plant variety patent protection; (2) biological pharmaceuticals and biosimilars; (3) whether protection is available for diagnostics and gene patenting; and (4) any specific peculiarities in each country in obtaining and maintaining patent protection (i.e., compulsory licensing issues). The speakers will be:

Ignacio Manuel Sanchez Echagüe, Marval O’Farrell & Mairal, Buenos Aires, Argentina

Leonor Galvão de Botton, Murta Goyanes, Rio de Janeiro, Brazil

Luis Diego Castro, Castro & Pal Asociados, San José, Costa Rica

Eugenio Pérez, Uhthoff, Gómez Vega & Uhthoff, Mexico City, Mexico

May 2, 3:30 – 5:30, “Reverse Payments” – Food and Drug, Antitrust, ADR Joint Session

Biotech members may want to be aware of a session that conflicts with our joint CLE session with IP Practice in Latin America (see above).  The Food and Drug, Antitrust, and Alternate Dispute Resolution committees have planned a panel on so-called “reverse payment” settlements in ANDA litigations, which is the topic of the FTC v. Actavis case before the US Supreme Court this term.  The anticipated panel includes Steve Shadowen of Hilliard & Shadowen LLC, Guy Donatiello of Endo Pharmaceuticals Inc., an economics professor offering an economic perspective, and a representative of the ADR committee.  Look for additional details on this topical panel in April issue of the Biotech Buzz.

Biotech Social, Seattle Westin Hotel, Thursday, May 2, 5:30 – 6:30.

Please join us for drinks, light hors d’oeuvres, and socializing with panelists and committee members at a place yet to be selected within the Seattle Westin Hotel after our CLE sessions on Thursday.  ~5:30 – ~6:30.  As usual, it’s a cash bar.

AIPLA Trip to Mexico City—June 5-7, 2013

AIPLA members, including AIPLA’s Executive Director, Todd Dickinson, AIPLA’s current President, Jeffrey Lewis and at least one of the AIPLA’s Board Members, Mike Martinez, will be visiting Mexico City June 5th-7th in 2013.  Biotech committee members would be welcome to attend.  If you wish to be part of AIPLA’s delegation, go to http://www.marriott.com/hotels/travel/mexjw-jw-marriott-hotel-mexico-city/ to book your room directly over the Internet.  The normal rate is $399.99 plus tax, per night.  However, we were able to obtain a group preferred rate of $237.00 plus tax, per night.  The Group Code to use over the Internet is AIPAIPA.  If you book your rooms over the phone, then the Group Code is simply AIPLA.  If you are attending, book your room immediately and then please let James Larson know.

Webinars

Myriad: Mirth or Melancholy? Date TBD – Soon after Supreme Court decision

The AIPLA Biotech Committee plans to put on a webinar about Myriad soon after the Court issues its decision.  So far Professor Joshua Sarnoff, counsel for amici curiae “Fifteen Law Professors, and Barbara Rudolph of Finnegan Henderson have confirmed their participation.  We expect Greg Castanias, who argued for Myriad at the Court, to participate, and we are hopeful that one of the plaintiffs’ attorneys will also participate.  Stay tuned for the date and time of the webinar and the full list of presenters.

Reprise of Spring Meeting Joint Session on Biotechnology IP Practice in Latin America (120 Minutes of CLE), Date TBD

The Biotechnology Committee and the IP Practice in Latin America Committee will collaborate to present 2 hours of CLE via webinar on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. See above for specific topics and presenters.

Case Law Reports

Case Law Report Link

The Association for Molecular Pathology, et al, v. Myriad Genetics, Inc. et al.

Reported by Victoria S. Lee and Amelia F. Baur, PhD, Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, D.C., USA.

 

No. 12-398 (Sup. Crt. April 15, 2013) (summary of U.S. Supreme Court oral arguments in case related to patentability of isolated DNA). 

Berish Rubin and Sylvia L. Anderson v. The General Hospital Corporation.

Reported by Rachel L. Carnaggio, Fennemore Craig, P.C., Denver, Colorado, USA.

 

No. 2011-1439 (Fed. Cir. Mar. 28, 2012) (inventorship dispute between independent research teams gives rise to an interference because the parties were not collaborating). 

Biosimilars Subcommittee

Momenta Seeks Supreme Court Review of Whether Safe-Harbor Applies to Post-Approval Uses of a Drug

Contributed by Angie Sebor and Vicki Norton.

Following split decisions by the Federal Circuit in Classen Immunotherapies, Inc. v. Biogen IDEC, GlaxoSmithKline & Merck & Co., 659 F.3d 1057 (Fed. Cir. 2011) and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), Momenta has petitioned the Supreme Court to consider the scope of the safe harbor under 35 U.S.C. § 271(e)(1).  More specifically, the Question Presented by Momenta in its petition is “[w]hether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as ‘solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs.’”  Amphastar initially waived its right to file a response to the petition, but the Supreme Court called for a response, which suggests to some commentators that the Court is showing interest in the case.  Amicus briefs in support of Momenta are due on May 2, 2013.  If the Supreme Court decides to hear the Momenta case, it could resolve the recent split decisions by two Federal Circuit panels and provide more certainty to biologic drug and biosimilar manufacturers.  In Classen, GSK had also petitioned for certiorari, but the Supreme Court denied GSK’s petition on January 14, 2013.

The Federal Circuit panels deciding both Classen and Momenta were divided on the issue of whether 35 U.S.C. § 271(e)(1) can shield post-approval use of a patented technology.  Judge Newman wrote for the majority in Classen, addressing the question of whether §271(e)(1)’s safe harbor shielded the defendants’ post approval activities from infringement where Classen’s method patents were directed to methods of screening and identifying immunization schedules associated with lower risk of chronic disease.  The defendants’ post-approval activities included evaluating suggested associations between vaccines, reporting on recommended immunization schedules, and reporting adverse vaccine effects to the FDA.  The Federal Circuit majority reversed the district court’s ruling that the defendants’ activities fell within the § 271(e)(1) safe-harbor provision and held instead that the safe harbor is “limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions” and that the “statute does not apply to information that may be routinely reported to the FDA long after marketing approval has been obtained.”  Judge Moore dissented, opining that the majority’s analysis and construction of the safe harbor provision were “contrary to the plain language of the statute and clear Supreme Court guidance” (referencing Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)), and “[n]owhere does that statute limit the safe harbor to pre-approval uses.”

In Momenta, Judge Moore wrote for the majority, reaching a conflicting result by holding that Amphastar’s use of Momenta’s patented process for analyzing drug quality during the manufacture of enoxaparin for commercial sale fell within the safe harbor.  Amphastar argued that because the continued testing was an FDA condition for marketing approval, its post-approval testing fell within the plain language of the safe harbor of §271(e)(1).  The Federal Circuit panel majority sided with Amphastar, concluding that the language of §271(e)(1) is broad and “unambiguously applies to submissions under any federal law, providing that the law ‘regulates the manufacture, use or sale of drugs’, and is not only directed to activities related to submission for FDA approval.  The court further held that the phrase “reasonably related to the development and submission of information” in the statute does not mean that the use of the patented invention must necessarily result in the actual submission of information to the FDA—the majority found that Amphastar’s requirement to retain testing records to be readily available for authorized inspection by the FDA upon request satisfied the requirement.  In a dissenting opinion,Chief Judge Rader urged that Amphastar’s activity was not solely for developing and submitting information to the FDA, but also for manufacturing a product to sell in commerce.  Chief Judge Rader further commented that by ignoring the meaning of the term “solely” in the statute, the majority expanded the limited reach of §271(e)(1), to “essentially render manufacturing method patents worthless.”

The Biosimilar Subcommittee will continue to monitor the Momenta case, and will provide a more in depth report on the impact of Classen and Momenta following a Supreme Court ruling on the merits, or its denial of Momenta’s petition.

 

Summary of FDA Draft Guidance on Formal Meetings for Biosimilar Development Programs

Contributed by Vicki Norton, Duane Morris LLP, San Diego, California, USA.

 

On March 11, 2013 the FDA issued a “Draft Guidance on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (“Draft Guidance”) (see also 78 Fed. Reg. 19492, April 1, 2013). 

Following enactment of the Biosimilar User Fee Act of 2012 (BsUFA), FDA had committed to achieving certain performance goals in a BsUFA goal letter from the Secretary of HHS to Congress (“FDA Commitment Letter”), including management goals for formal meetings that occur between the FDA and sponsors or applicants during development of a biosimilar biological product. 

The Draft Guidance provides a unified approach to the formal meetings between sponsors or applicants and the FDA during the development of biosimilar products.  In addition, the Draft Guidance discusses principles of good meeting management practices (“GMMPs”) and describes standardized procedures for requesting, preparing, scheduling, conducting and documenting the formal meetings.  The Draft Guidance describes five types of formal meetings and targeted dates: 

The Biosimilar Initial Advisory meeting is the FDA’s initial assessment limited to a general discussion regarding whether licensure under section 351(k) of the Public Health Services Act may be feasible for a particular product, and, if so, general advice on the expected content of the development program.  These meetings should be scheduled within 90 calendar days of FDA receipt of a written meeting request and meeting package.

No user fee is due for the Biosimilar Initial Advisory meeting.  However, fees for the remaining four Types of Biosimilar Product Development (BPD) meetings must be paid in advance?

A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled BPD program to proceed, and include meetings to discuss clinical holds, special protocol assessment meetings after receipt of FDA evaluation of protocols, meetings to discuss important safety issues, and dispute resolution meetings.  BPD Type 1 meetings should be scheduled within 30 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 2 meeting is a meeting to discuss a specific issue such as proposed study design or endpoints, or to discuss questions where the FDA will provide targeted advice regarding an ongoing BPD program.  This meeting includes substantive review of summary data but does not include FDA review of full study reports.  BPD Type 2 meetings should be scheduled within 75 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 3 meeting is a meeting to provide in-depth data review and advice regarding an ongoing BPD program, including substantive review of full study reports, FDA advice regarding the similarity between the proposed biosimilar biological product and the reference product, and FDA advice regarding the need for additional studies, including design and analysis.  BPD Type 3 meetings should be scheduled within 120 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 4 meeting is a meeting to discuss the format and content of a biosimilar biological product application or supplement to be submitted under section 351(k).  BPD Type 4 meetings should be scheduled within 60 calendar days of FDA receipt of a written meeting request and meeting package.

The five types of formal meetings were previewed in the FDA Commitment Letter and the related Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017 (76 Fed. Reg. 76424, December 7, 2011).  However the Draft Guidance indicates that an overview of the proposed development be provided and specifies that the biosimilar application provide preliminary comparative analytical similarity data to enable the FDA to make a preliminary determination as to whether licensure under section 351(k) of the PHS Act may be feasible for a particular product. 

Itemized details of what the Meeting requests should include are summarized:   

1. Product name. 2. Application number (if applicable). 3. Proposed proper name (or proper name if post-licensure). 4. Structure (if applicable). 5. Reference product name. 6. Proposed indication(s) or context of product development. 7. The type of meeting, along with the rationale for requesting the meeting type. 8. A brief statement of the purpose of the meeting, including a brief background of the issues underlying the agenda.  It also can include a brief summary of completed or planned studies and clinical trials or data to be discussed at the meeting, the general nature of critical questions to be asked, and where the meeting fits in overall development plans.   9. A list of the specific objectives/outcomes the requester expects from the meeting. 10. A proposed agenda, including estimated times needed for each agenda item. 11. A list of questions, grouped by discipline. Each question should be precise, and there should be a brief explanation of the context and purpose for each question. 12. A list of all individuals who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants. 13. A list of FDA staff, if known, or disciplines, asked to participate in the requested meeting. 14. Suggested dates and times for the meeting that are within or beyond the appropriate time frame of the meeting type being requested. 15. The proposed format of the meeting (i.e., face-to-face meeting, teleconference, or videoconference) (see Section VI of the Draft Guidance).

Items 8-14 elaborate on items 1(a-g) previously outlined in the FDA Commitment Letter, while items 1-7 in the Draft Guidance appear to relate to background information on the proposed biosimilar development program.  In other respects, the discussion of the 5 types of formal meetings in the Draft Guidance largely tracks earlier FDA’s earlier description of the five types of formal meetings.

Comments on the Draft Guidance are due May 31, 2013.

 

International Issues Subcommittee

Europe: A Family Affair: How claims of a “mother” patent were found to lack novelty in view of a “daughter” divisional application

Contributed by René Raggers, EP&C, Utrect, The Netherlands

 

The Technical Board of Appeal of the European Patent Office (EPO) recently determined in decision T 1496/11 that a divisional application (“daughter”) can be prior art against its own mother application.

Although the patent in this case is not “biotech” it is a good example on how the EPO looks at “self-collision” and validity of priority claims:

Under the European Patent Convention Article 54(3), European patent applications with an earlier filing or priority date than the filing or priority date of a second European patent application, and which are published on or after the filing date of that second application, are prior art  for the purpose of examining the novelty of this second patent application.

Thus in the below example patent application A is prior art for novelty only for patent application B, although published after the filing of B:

 

T 1496/11 concerns a “mother” application and a “daughter” application that both claimed priority from the same Australian application.

The mother was patented with claim 1 relating to a “optical lens”. However, the priority document disclosed such “optical lens” only in combination with a “printed or embossed feature.” The Board held that the claim of the mother patent was not entitled to the priority date, because the claims could be practiced with or without using a “printed or embossed feature.”

Since the filed “daughter” applications was identical to the priority document, it thus became relevant under Article 54(3) (divisional) for claim 1 of the mother application (the daughter having an earlier priority date than claim 1 of the mother, and being published on or after the filing date of the mother). Since the description disclosed “an optical lens in combination with a printed or embossed feature”, the daughter takes away novelty of claim 1 of the mother.

 

This case shows the EPO’s strict view on the right to priority and provides consideration when prosecution patent applications before the EPO.

Plant IP Protection in Australia

Contributed by David Myers and Andrew Blattman of Spruson & Ferguson (Sydney)

 

Australia has a significant agricultural industry, with a gross value of crops in the order of 20 billion dollars annually (including cereals, cotton and canola, but also a significant fruit and vegetable sector). Moreover, the Australian industry is technology intensive, and new plant varieties developed in Australia or overseas are quickly being adopted to meet yield, market, disease and climatic demands.

Importantly, plants (including genetically modified plants) can be protected under both the Australian Plant Breeders Rights Act 1994 (the “PBR Act”) and the Australian Patents Act 1990, and protection under one system does not preclude obtaining concurrent protection under the other.

Plant breeders rights

A variety (plant, fungus or alga) is defined by a combination of physical, chemical or other biological (including disease resistance) characteristics expressed by the variety.  At least one characteristic must distinguish the variety from other commonly known varieties in order to be registrable.  The variety must also be “uniform” in the characteristics it expresses and be “stable” when bred over a number of generations.  The variety need not be previously undisclosed or even uncommercialised; commercial exploitation can occur in Australia up to one year before application, and can occur overseas (in UPOV member countries) up to four years before the making of the PBR application for most plants, or up to six years for trees and vines.  UPOV convention priority from a foreign application can be claimed, although this usually introduces prosecution complications and limitations, and is typically not necessary.

Examination of a PBR application usually requires the involvement of an expert for inspection of the variety and reporting to the PBR Office.  Relevant overseas DUS (Distinctiveness, Uniformity and Stability) test reports can facilitate examination, although a Qualified Person is still required to review such reports and file a report at the Australian PBR Office.

Before grant of a PBR, a deposit of propagating material must be made at an approved Genetic Resource Centre (GRC), and maintained thereafter for the duration of PBR protection.

PBR protection for a plant variety starts as ‘provisional protection’ during prosecution of the application (from the date the application passes formalities examination) and then officially starts from the date of grant of the PBR right and extends for up to 20 years for most plants and up to 25 years for varieties of trees and grape vines.

Protection under the PBR Act includes an exclusive right to produce or reproduce propagating material from the variety, and to sell, condition for sale, import or export such material.  Under limited circumstances, rights may extend to material harvested from the variety.  Rights may also extend to “essentially derived varieties”.  Exemptions to PBR infringement include use of a registered variety privately, for non-commercial purposes or for breeding other plant varieties.  A further exemption exists for farm-saved seed.

Independent of the usual infringement remedies (damages, account of profits and/or delivery up and destruction), the PBR Act also provides for prescribed penalties for infringement.

Patent rights

Patents legislation may provide a plant variety with protection for a period of up to 20 years, from the date of filing of the patent application.

In order to be patentable, a plant variety must meet the usual requirements, including that:

•      the plant be novel in an absolute sense, non obvious, and obtained using a reproducible method;

•      the plant exhibits improved or altered useful properties; and

•      derivation of the plant involves human intervention.

In deciding what constitutes human intervention, the Australian Patent Office treats the choice of parents and their selective breeding, followed by selection of the most desirable offspring as being sufficient.

Where an aspect of the invention claimed cannot be performed without a sample of the germplasm (which is most likely to be the case for a plant variety), a deposit at a Budapest Treaty Depository will most likely need to be made before the filing date of the patent application.

The scope of protection afforded by the patents system is significantly broader than that afforded by PBR.  Unlike PBR, a patent allows protection for the plant variety per se, as well as for:

•      any part of the plant (including harvested material, genes, proteins, other molecules);

•      use of the plant variety or its part(s);

•      methods of breeding plants using the protected variety and resulting progeny; and

•      products derived from the plant.

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